Comparison · NCT03365791-sae
PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: serious adverse events. Trial comparisons, record NCT03365791-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03365791-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.408 | 0.304 | 0.52 | wilson | |
| Risk in group 2 | 0.0526 | 0.0207 | 0.128 | wilson | |
| Risk difference, group 1 minus group 2 | 0.355 | 0.227 | 0.472 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 7.75 | 2.88 | 20.9 | log | |
| Odds ratio, group 1 over group 2 | 12.4 | 4.1 | 37.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PDR001+LAG525 On-treatment Period than on PDR001+LAG525 Extended Safety Follow-up Period | 2.81 | 2.12 | 4.4 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PDR001+LAG525 On-treatment Period | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001 | 31 | 76 | EG000 |
| Group 2 | PDR001+LAG525 Extended Safety Follow-up Period | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001 | 4 | 76 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
In the on-treatment period, adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment. In the extended safety follow-up period, AEs and serious AEs (including the All-Cause Mortality data table) are presented from day 31 to day 150 after last administration of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
- NCT number
- NCT03365791
- Phases
- PHASE2
- Conditions
Small Cell Lung Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Castration Resistant Prostate Adenocarcinoma, Soft Tissue Sarcoma, Ovarian Adenocarcinoma, Advanced Well-differentiated Neuroendocrine Tumors, Diffuse Large B Cell Lymphoma
- Interventions
- PDR001, LAG525
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03365791?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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